Bhupesh Pratap
Clinical Manager @Rosemont Pharmaceuticals
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WORK HISTORY
Clinical Manager @Rosemont Pharmaceuticals
Leeds, GB
Supporting one UK-based in house R&D and 5 India-based R&D centres for early phase development including BA/BE studies and late clinical phase development.• Physiologically Based Pharmacokinetic Modelling: Led and mentored the team for more than 8 PBPK-based FDA/EU submissions supporting formulation variables, dissolution limit widening, and in-vivo prediction.• Clinical Pharmacology: Led a team of 2 Pharmacokinetic scientists, clinical pharmacologists, and Biopharmaceutics scientists, mentoring them to devise and organize more than 40 early development pilot and pivotal scale studies per year across more than 10 International CROs.• Pre-IND and PREA Submissions: Mentoring team for authoring more than 10 Pre-IND and PREA submissions to support IND and future 505 (B2) applications.• Patients Pediatric PK/PD studies: Worked closely with Global CROs for designing protocol, execution, monitoring, data analysis, regulatory support, and deficiency response for 2 pediatric PK /PD endpoint studies.• Pharmacodynamic End Point studies: More than 5 clinical trials with PD endpoints for liquid oral and transdermal dosage forms.• Immunogenicity studies for peptides: Led and mentored team for 3 preclinical and in-vitro (Innate and adaptive immunity) studies running in collaboration with International CROs.• Regulatory communications: Authoring, reviewing, and mentoring team for more than 20 controlled correspondences, Pre IND, Pre NDA, PDM submissions, scientific advice and deficiency responses.• PK/PD support for 505(b)(2): Part of the governance committee for building rational, formulation identification, relevant dissolution media selection and championing the preclinical proof of concept and Pharmacokinetics and clinical pharmacology strategies for 505(b)(2) program.
EDUCATION
National Institute of Pharmaceutical Education and Research
M.S. (Pharmacology and Toxicology), M.S
BBDNITM, Lucknow, U
B. Pharm, B. Pharm
ORIENTAL UNIVERSITY
Doctor of Philosophy - PhD, Pharmaceutical Sciences
SKILLS
ABOUT BHUPESH PRATAP
With 18 years of progressive experience in the pharmaceutical industry, I have consistently driven scientific leadership and strategic innovation in PBPK mechanistic modeling, clinical pharmacokinetics, bioavailability, and bioequivalence. My expertise spans early and late-phase clinical trials, delivering transformative solutions and operational excellence in drug development.As a senior leader in clinical pharmacology, I have led high-impact collaborations with Regulatory authorities and CROs to evaluate scientific, regulatory, and operational data strategically. My breadth of knowledge covers small and medium molecule development, including solid oral, liquid dosage forms, complex injectables, and transdermal systems—ensuring regulatory compliance and market success.Key Leadership Achievements Strategic Direction: Led global Clinical Pharmacology initiatives, aligning regulatory compliance with innovation and efficiency in drug development programs. Scientific Leadership: Directed cross-functional clinical teams, overseeing bioequivalence studies, preclinical research, clinical trials, and bioanalytical activities across international markets. Data-Driven Decision-Making: Designed and implemented preclinical and clinical strategies, integrating PBPK modeling, Caco-2 permeability, toxicology, and immunogenicity studies to strengthen regulatory submissions. Operational Excellence: Led outsourced bioavailability and pharmacokinetics services, optimizing quality, cost, and timelines through strategic CRO partnerships. Innovation & Advanced Tools: Designed and executed bioequivalence studies for complex generics, leveraging state-of-the-art platforms like WinNonlin, GastroPlus, SymCyp, and IVIVC modeling tools to enhance predictive accuracy. Regulatory & Commercial Success: Spearheaded the submission of 200+ ANDAs and 15+ 505(b)(2)/IND applications, demonstrating deep regulatory acumen and a results-driven approach to drug approvals.By blending technical expertise with strategic leadership, I have consistently delivered high-impact outcomes in clinical pharmacology and regulatory affairs, accelerating drug development and ensuring market success.
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